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Pharmaceuticals
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Validated Control and Information Systems
These Flexible Batch Systems provide truly "programmable" production facilities. Recipe-reading system logic instructs either a controller or an operator at every step of the production process. Recipes specify manual tasks, ingredient formulation, processing steps and all the control parameters for each operation. The opportunity for operators to make a sequence-of-steps error is eliminated by the system that presents instructions from the recipe in the same manner each time. Recipes control both production operations and maintenance tasks. Even the CIP and SIP processes are done with recipes. Operators can't use equipment that is not cleaned or sterile because the system tracks the status of each item. Scheduling of batches is easier because operators know the status of each piece of equipment needed for each pending batch. Electronic Signatures (ES) and automatically generated Electronic Batch Records (EBR) ensure the integrity of product and associated records. Manufacturing Execution Systems (MES) provide communication to IT applications and databases. Our shop floor systems include MES functionality and interfaces. Planning, quality and inventory data, required to and from control systems, is passed securely and quickly to control points that support decision making. Using formal proven standards and methodologies, we document each system's history and design details needed to support IQ and OQ testing, and regulatory audits. |
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